A Phase 3 Clinical Study of KHK4827

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01782924
First received: January 27, 2013
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

This study is designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.


Condition Intervention Phase
Psoriasis
Drug: KHK4827
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: An Extension Study in Subjects With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Incidence and types of adverse events and adverse reactions [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory values and vital signs [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Development of anti-KHK4827 antibody [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • sPGA of "clear (0)" [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Body surface area involvement (BSA) of lesion [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Profiles of pharmacokinetics [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Concentration of KHK4827 in serum


Estimated Enrollment: 140
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KHK4827 140mg SC Drug: KHK4827
Experimental: KHK4827 210mg SC Drug: KHK4827

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has voluntarily signed the written informed consent form to participate in this study
  • Subject has completed the week 12 evaluation of Study 4827-002

Exclusion Criteria:

  • Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
  • Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782924

Locations
Japan
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Chiyoda-ku, Tokyo, Japan, 100-8185
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01782924     History of Changes
Other Study ID Numbers: 4827-003
Study First Received: January 27, 2013
Last Updated: July 26, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014